CD&D, and Staff Reports

A small Austrian company has introduced an innovation for continuous blood pressure monitoring so simple that, once seen, you have to ask why no one thought to do this before. Yet this elegantly low-tech technique opens a new potential for adding existing technologies that taken together could disrupt the current market for blood measurement during surgery.

CNSystems Medizintechnik (Graz, Austria) won FDA approval just one week ahead of this past November's MEDICA 2008 exposition in Dusseldorf, Germany, for its CNAP Monitor 500, which measures arterial blood pressure via a sensor sleeve placed over the patient's fingers. The monitor has been available for sale in Europe since June.

Measuring blood pressure during surgical procedures is critical to monitoring the patient under sedation. When patient blood volume state is maintained in an optimum range, anesthesiology studies show post-operative recovery can be reduced from 17 days to just seven.

The trend toward goal-directed fluid volume management is delivering improved patient outcomes and substantial savings for hospitals, which explains the steadily increasing competition and sales for cardiac monitoring in recent years.

Currently the only technique for continuous blood monitoring of patients during operations is an invasive needle inserted into an artery that also has the advantage of providing blood gas measures but increases the risks for infection and has potential for damaging the artery

The majority of patients in surgery are monitored using the traditional blood pressure cuff placed on the upper arm. "This method not only compresses the arm but also occludes the artery, and if you do it every three minutes to step up the frequency, you will have a lot of bruising," explained Christopher Arbeiter, head of sales and marketing at CNSystems.

The CNAP Monitor 500 displays on a large, anti-reflective screen a high-fidelity blood pressure curve, the beat-to-beat blood pressure values, the patient's pulse rate and then a trend view of blood pressure and pulse rate.

With real-time continuous readings, CNSystems is targeting the 82% of procedures that already are non-invasive, using the blood pressure cuff.

While selling the new monitor to hospitals through its own distributor network, CNSystems also supplies the CNAP Monitor 500 to original medical equipment manufacturers.

Three German companies who have integrated the unit into their own product lines are Draeger (L beck), Medis Medizinische Messtechnik (Ilmenau) and Enverdis (Jena). Draeger introduced the monitor at MEDICA as the Infinity CNAP SmartPod.

Because this cuff slips over two fingers, there is the obvious possibility of integrating infrared sensors, which would provide oxygen saturation readings, Arbeiter said, explaining that inputs from the finger cuffs can be plugged into any existing surgical monitor.

"This would become a very disruptive product for the SpO2 game" that is led by the Masimo (Irvine, California) and Covidien's (Mansfield, Massachusetts) Nellcor (Boulder, Colorado) unit as the two biggest manufacturers, he said.

"They have a good business selling probes, yet we only need to add software to our device to do the same thing, and that is a no-cost add-on feature," he added.

"So we are moving carefully right now in approaching the U.S. market, because there is more than one big company looking to do a crossover of their product with this device," Arbeiter said.

Elsewhere in the product pipeline:

• Aastrom Biosciences (Ann Arbor, Michigan) said the first patient was treated in its Phase II IMPACT-DCM trial designed to evaluate the company's Cardiac Repair Cells in dilated cardiomyopathy. The 20-patient study is expected to test the surgical delivery of autologous cells directly into human heart muscle for DCM-related congestive heart failure. Patients will be treated with Aastrom's CRCs, an autologous, mixed-cell product containing expanded populations of stem and early progenitor cells. The primary objective is to assess safety, though the firm will evaluate efficacy measures, including left ventricular ejection fraction, heart failure stage and other measures of cardiac function. Patients in the study will be followed for 12 months post treatment.
• Access Scientific (San Diego) said it has received FDA clearance for its MicroAccess WAND, which it says is the world's first all-in-one safety introducer. This device helps clinicians to more quickly and safely insert a sheath or catheter into the peripheral vasculature. The MicroAccess WAND is expected to be used primarily in interventional radiology suites and cardiac catheterization labs. "The MicroAccess WAND is the first device to enable clinicians to perform the Accelerated Seldinger Technique, which we believe is the ultimate refinement in vascular access technology," said CEO Steve Bierman, MD.
• Aldagen (Durham, North Carolna) reported positive results from its 21-patient Phase I/II trial of Ald-301, a stem cell therapy in development for critical limb ischemia. Data from the 24-week study showed that the compound was well tolerated. Results from the 12-week study showed that the compound was well tolerated. Results from the 12-week efficacy assessment period demonstrated improvements in overall clinical status as well as increased blood flow in affected limb imn the group of patients treated with Ald-301. Four of the 11 patients in the ALD-301 arm improved in Rutherford category and were no longer categorized as having critical limb ischemia.
• ATS Medical (Minneapolis, Minnesota) said it has received FDA clearance for the marketing of the ATS 3f aortic bioprosthesis that includes a new sewing tab material supplier and an improved valve holder accessory device. The ATS 3f is a stentless pericardial aortic tissue valve that is unlike any other valve. The tubular design of the ATS 3f maintains the continuity of the annulus and the sino tubular junction. The ATS 3f preserves the aortic sinuses and restores native valve stress distribution and physiologic blood flow.
• Biopure (Cambridge, Massachusetts) reported that the U.S. Naval Medical Research Center (NMRC) submitted a revised investigational new drug application to the FDA to conduct a trial of the company's oxygen therapeutic Hemopure (hemoglobin glutamer-250 bovine) for the prehospital battlefield treatment of trauma patients. The NMRC submitted and subsequently withdrew a protocol for a Phase II trial of Hemopure for resuscitation of operations casualties with severe traumatic hemorrhagic shock, when blood transfusion is not available.

The proposed trial hypothesis is that for such casualties Hemopure will improve survival and other clinical parameters. Under a research agreement with Biopure, the NMRC assumed primary responsibility, subject to funding, for designing, seeking FDA acceptance of and directing a trial for Hemopure's prehospital use in trauma patients with hemorrhagic shock.

• Cardica (Redwood City, California) reported publication of a case study in the September issue of the Journal of Neurosurgery featuring the use of Cardica's C-Port xA distal anastomosis system to connect blood vessels in the brain to bypass an enlarging aneurysm. Using the C-Port system, neurosurgeons bypassed the aneurysm using a saphenous vein graft extending from the extracranial common carotid artery to the intracranial middle cerebral artery. The C-Port system performed an automated anastomosis by inserting 13 tiny staples into the graft and recipient vessel. The bypass was demonstrated to be patent (open) on intraoperative and postoperative arteriography, and the patient subsequently made a good neurologic recovery. By replacing hand-sewn sutures with easy-to-use automated systems, Cardica's products provide cardiovascular surgeons with rapid, reliable and consistently reproducible anastomoses, or connections of blood vessels, often considered the most critical aspect of the CABG procedure.
• CardioDynamics (San Diego) reported on two studies which correlate BioZ with Ejection Fraction (EF) from echocardiography (echo). Researchers from Stanford Medical Center (Stanford, California), reported results of a pacemaker optimization study at the Heart Failure Society of America annual meeting. The study's purpose was to identify a method more suitable than echo for routine use in pacemaker optimization. Researchers compared ICG and echo both in terms of data quality and ease of use. The researchers concluded that the BioZ ICG provided more precise optimization of pacemaker patients than echo, and ICG had the added benefit of not requiring any manual measurement or subjective interpretation.
• Evalve (Menlo Park, California) said that long-term data published in EuroIntervention showed that the expected decrease in Mitral Vale Area (MVA) after repair with the MitraClip system to correct mitral regurgitation (MR) is not associated with clinically significant mitral stenosis. Additionally, with two years of follow-up, none of the patients treated with the MitraClip system required surgery for mitral stenosis. At 12 months no important differences were reported between the use of one or two MitraClip devices or based on the etiology of MR. The analysis was conducted to assess diastolic mitral valve function after percutaneous repair. Echocardiographic measurements of MVA and mean trans-Mitral Valve Gradient (MVG) were made in 96 patients implanted with the MitraClip device. The MitraClip system provides a non-surgical mitral valve repair option for patients suffering from the effects of MR. The device creates a double orifice mitral valve by securing the leaflets to reduce MR in a replication of the surgical procedure. The resulting double orifice has an inherently smaller cross sectional area compared to the native mitral valve.
• ICON (Dublin, Ireland) said its Medical Imaging division (Warrington, Pennsylvania) has launched a new cardiac echocardiography analysis software solution. The software, MIRA-ECHO, enables cardiac echocardiography (ECHO) images to be viewed, measured and interpreted in clinical trials and is the latest addition to ICON Medical Imaging's MIRA (Medical Imaging Review and Analysis) platform. MIRA-ECHO is a digital DICOM (Digital Imaging and Communications in Medicine) image viewer and analysis software module that is integrated with an eCRF (Electronic Case Report Form). It displays links from the traced images back to the measured moving heart image, and also to the numerical measurements captured in the eCRF. Functionality embedded within the eCRF allows a physician to adjust preliminary measurements, while maintaining compliance with 21 CFR Part 11 regulations. MIRA-ECHO also enables measurement and assessment of the full complement of ECHO parameters.
• InterCure (New York) reported the U.S. release of its next-generation hypertension treatment device, RESPeRATE Ultra. The RESPeRATE Ultra was designed with input from thousands of RESPeRATE users. It features a large, enhanced display, fewer buttons and a simple menu; the unit was crafted to not only provide the same blood pressure reduction results as its predecessor, but also provide an enhanced, pleasurable device-guided breathing experience. The RESPeRATE Ultra also includes an interactive tutorial that guides the user to quickly learn to use the device to most effectively lower his or her blood pressure.
• Lumen Biomedical (Plymouth, Minnesota) said its FiberNet Embolic Protection System (EPS) has received FDA clearance for the treatment of patients receiving endovascular intervention for carotid artery disease. The approval follows the recent release of EPIC clinical study data demonstrating the lowest stroke rates of any filter currently available on the U.S. market. The FiberNet EPS captures debris released during the stenting procedure and prevents it from traveling to the brain, where it has the potential to cause a stroke. Lumen says that the defining attribute of the FiberNet filter lies in the 3-D design, comprised of a matrix of fibers, allowing for better capture efficiency. The low-profile filter is mounted on a guide wire, needing no delivery system to cross the lesion. Remote actuation deploys the fiber-based filter - treating vessels ranging from 3.5 mm to 7.0 mm - filling the vessel and ensuring "excellent wall apposition," according to the company. After the particles have been captured, the FiberNet filter is retrieved into the retrieval catheter under aspiration, and removed from the patient.
• Medtronic (Minneapolis) reported the U.S. market launch of the Endeavor Sprint drug-eluting stent (DES) on a rapid exchange (RX) delivery system. Using the Sprinter balloon catheter technology, the Endeavor Sprint system puts the Endeavor DES on an enhanced delivery platform, making Medtronic's flagship DES even easier for physicians to deliver to the site of coronary blockages, the company said. Medtronic also received FDA approval of the Sprint Quattro Secure S single-coil defibrillation lead (Model 6935) for use with implantable defibrillators in patients at risk for dangerous tachyarrhythmias and sudden cardiac arrest. This new defibrillation lead is an addition to the Sprint Quattro family that is supported by more than seven years of post-market performance data. It provides an option for physicians who prefer a specific type of lead for patients with unique anatomies and is designed to help reduce tip pressure. The lead is designed with an 8.6 Fr lead body. A thin wire inserted into the chambers of the heart through blood vessels, the lead is compatible with any Medtronic implantable cardioverter-defibrillator or cardiac resynchronization therapy-defibrillator. Separately, Medtronic reported the U.S. market launch of the Sprinter Legend (semicompliant) and the NC Sprinter (noncompliant) balloon dilatation catheters on a rapid-exchange delivery system. The Sprinter Legend balloon catheter features the lowest pre-dilatation profiles on the market, making it suitable for use in challenging lesions, as well as allowing for the use of two balloons simultaneously in a small, 6 Fr guide catheter (known as the "kissing balloon" technique). The Sprinter Legend balloon catheter is being launched in a wide variety of sizes, covering diameters of 1.5 mm to 4.0 mm and lengths of 6 mm to 30 mm.
• Pressure Products (Los Angeles) has received FDA clearance to distribute the SafeSept transseptal guidewire. This device is used in conjunction with a standard Brockenbrough transseptal needle when performing a transseptal crossing in the setting of atrial fibrillation and other invasive and electrophysiological atrial bi-chamber cardiology procedures. The SafeSept Transseptal Guidewire is a novel guidewire designed to easily perforate the interatrial septum, immediately become atraumatic in the left atrium, enable fluoroscopic confirmation in the pulmonary veins, and allow safer over-the-wire advancement of the transseptal needle, dilator and introducer sheath into the left atrium.
• Siemens Healthcare (Malvern, Pennsylvania) introduced the Somatom Definition Flash CT scanner. "It uses less radiation for scanning and is much faster than the current technology available," he said during a web conference. The Somatom Definition Flash is a new dual-source CT, featuring two X-ray tubes that simultaneously revolve around the patient's body. Because of Somatom's scanning speed, patients are no longer required to hold their breath during the exam the way they had in the past. At the same time, the Somatom Definition Flash operates at an extremely reduced radiation dose. Currently the average effective dose for a heart CT scanner ranges from 8 milliseconds to 40 milliseconds. The new scanner gets by with less than 1 millisecond. The dose values of the new Siemens CT scanner are below those of an intracardiac catheter examination, thus opening up possibilities for using CT scanners for routine cardiological examinations. Siemens said a person with a height of 6 feet 6 inches could be scanned in less than 4.7 seconds. Previously such whole-body examinations took more than 10 minutes to perform from patient preparation to diagnosis. With the Somatom Definition Flash, this process is completed in just a few minutes. A scan of the entire heart can be performed in only 250 milliseconds, which is less than half a heartbeat. In addition, it is possible for physicians to reliably display a heart with a fast pulse or an irregular heartbeat without using beta blockers, thus simplifying the workflow and yielding clinical and financial advantages.
• Spectranetics (Colorado Springs, Colorado) reported FDA clearance for the Quick-Cross Extreme product line, which represents an extension of its Quick-Cross support catheters. The Quick-Cross Extreme product line is intended for use to guide and support a guide wire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents. It is designed to facilitate the crossing of blockages in the legs and features a braided catheter and an angled tip. The braided catheter jacket improves strength and pushability while the angled tip allows for quicker access into branched anatomy. This is an upgrade to the current Quick-Cross product line and is available for 0.035" guide wire compatibility in 65 cm, 90 cm, 135 cm, and 150 cm lengths.
• Terumo Interventional Systems (Somerset, New Jersey) reported the launch of Optitorque, its new line of coronary diagnostic catheters, featuring the Tiger and Jacky tip shapes designed and cleared specifically for transradial procedures. With a clockwise or counter-clockwise rotation, the Tiger and Jacky tip shapes enable angiography of both the RCA and LCA with one catheter. This eliminates the catheter exchange step and can potentially shorten procedure and fluoroscopic time. Terumo said that with its double-braided stainless steel mesh middle layer for superior (1:1) torque control and large lumen for high flow of contrast, the Optitorque's construction is the key to its outstanding performance.
• VivoMetrics (Ventura, California) said the company's LifeShirt system is being used by Concordia University (Montreal) to learn more about lifestyle factors that may put children at risk for developing cardiovascular diseases as they grow older. The LifeShirt is a lightweight, comfortable "smart garment," that children wear in their normal home environments, while the system continuously collects accurate vital sign data that will help researchers understand how physical activity, sleep patterns, eating habits and stress levels might put kids at later risk for heart disease. LifeShirt is a wearable, integrated RPM technology that continuously monitors multiple patient vital signs. The system provides researchers, physicians and healthcare providers with actionable insights into a patient's health via the monitoring and relational reporting of key life-sign functions including heart rate, respiratory rate, oxygen saturation, body position, activity level and skin temperature.